The Unimax Trocar System, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, and Thoracic Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

Device Description

The Auto-locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-locking Trocar is available from 3-15mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The cannula assembly has universal seal and stopcock.

The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 3-15mm The cannula assembly (10mm and 12mm type) has a universal seal, a valve, and a stpcock. The cannula assembly (5mm type) has a stopcock.

The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Visible Trocar is available from 5-15mm. Visible Trocar allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve, and a stopcock.

The Hasson Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Hasson Trocar is available from 3-15mm. This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.

The Dilating Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoacopic instruments. The Dilating Trocar is available from 3-15mm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock. There is a built-in universal seal.

The Secondary Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Secondary Trocar is available in 2 different lengths: 5mm/7cm and 5mm/10cm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock.

The Thoracic Trocar consists of a blunt-tipped obturator and a threaded cannula. It is designed for instrument stabilization and also protect against foreign materials entering the chest cavity. Once inserted into the chest, the Thoracic Trocar must be turned clockwise until it is securely seated in the tissue. There are four types of Thoracic Trocars: 6mm/7cm, 11mm/7cm, 13mm/7cm, and 15mm/7cm.

AI/ML Overview

The Unimax Trocar System's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Obturator Compatibility	Device functions as intended, allowing obturator and cannula to interface correctly without issues.	Meets requirements.
Insertion & Cannula Stability	Device can be inserted stably and the cannula remains stable without dislodgement or excessive movement.	Meets requirements.
Air Leakage	Minimal to no air leakage through the device to maintain pneumoperitoneum.	Meets requirements.
Biocompatibility (ISO 10993-1, 5, 10, 12)	No adverse biological reactions upon contact with tissues; appropriate for medical device use.	Meets requirements.
Sterilization (ISO 11135-1)	Device can be effectively sterilized by Ethylene Oxide (EO) to achieve sterility assurance level.	Meets requirements.
Safety Testing	No safety concerns raised during testing.	Meets requirements.

2. Sample Size and Data Provenance for Test Set

The document does not specify the exact sample sizes used for each performance test (Obturator Compatibility, Insertion & Cannula Stability, Air Leakage). The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, although it can be inferred that the testing was conducted by or for Unimax Medical Systems Inc., a company located in Taiwan. These were non-clinical bench tests performed on the device itself.

3. Number and Qualifications of Experts for Ground Truth

This information is not applicable. The Unimax Trocar System is a physical medical device, and the "ground truth" for its performance is established through objective engineering and safety tests rather than expert interpretation of medical images or clinical outcomes that would require expert consensus.

4. Adjudication Method for Test Set

This information is not applicable for a physical device undergoing performance and safety bench testing. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretations (e.g., medical image analysis) to resolve discrepancies among multiple expert readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices or AI-assisted systems where human reader performance is being evaluated with and without AI assistance. The Unimax Trocar System is a surgical instrument.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The document explicitly states: "A series of safety tests were performed to assess the safety and effectiveness of the Unimax Trocar System." And "The performance testing conducted on subject device and predicate device are listed below: Obturator Compatibility, Insertion & Cannula Stability, Air Leakage." The conclusion states, "After analyzing bench tests, safety testing data, it can be concluded that: Unimax Trocar System is as safe and effective as the predicate device."

7. Type of Ground Truth Used

The ground truth for the performance of the Unimax Trocar System was established through objective measurements and observation during non-clinical bench testing for physical characteristics (e.g., fit, stability, leakage) and through adherence to recognized international standards for biocompatibility (ISO 10993 series) and sterilization (ISO 11135-1).

8. Sample Size for Training Set

This information is not applicable. The Unimax Trocar System is a physical medical device, not an AI or machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

This information is not applicable as there is no training set for this device.

Summary

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K112358

Page 1. of 5

OCT 1 7 2011

Unimax Medical Systems Inc. 510(k) Notification

Unimax Trocar System

510(k) Summary

5.1 Type of Submission: Traditional
Preparation Date: 5.2 Aug 9, 2011

5.3 Revised Date:

5.4	Submitter:	Unimax Medical Systems Inc.
	Address:	8F-2, No. 127, Lane 235, Pao Chiao Rd., Hsin Tien, Taipei,Taiwan
	Phone:	886-2-89191698
	Fax:	886-2-89191528
	Contact:	Sophia Chiu
	Establishment Registration Number: 3007791595

5.5 Identification of the Device:

Proprietary/Trade name:	Unimax Trocar System
	Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, Thoracic Trocar
Common Name:	Disposable Surgical Trocar/Cannula
Classification Name:	Laparoscope, General & Plastic Surgery
Device Classification:	II
Regulation Number:	876.1500
Panel:	General & Plastic Surgery
Product Code:	GCJ

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K11 2358

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Unimax Trocar System

5.6 Identification of the Predicate Device:

Predicate Device Name:	ENDOPATH Bladeless Trocar, ENDOPATH Blunt Tip Trocar,ENDOPATH Dilating Tip Trocar
Manufacturer:	ETHICON ENDO-SURGERY, INC.
Product Code:	GCJ
510(k) Number:	K032676
Predicate Device Name:	Shielded Surgical Trocar
Manufacturer:	ETHICON ENDO-SURGERY, INC.
Product Code:	GCJ
510(k) Number:	K971475
Predicate Device Name:	ENDOPATH Disposable Thoracic Trocar Sleeve
Manufacturer:	ETHICON ENDO-SURGERY, INC.
Product Code:	GEA/GCJ
510(k) Number:	K920110

5.7 Intended Use and Indications for Use of the subject device.

5.8 Device Description

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Unimax Trocar System

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Unimax Trocar System

5.9 Non-clinical Testing

A series of safety tests were performed to assess the safety and effectiveness of the Unimax Trocar System. The safety tests were conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-12, and ISO 11135-1. The performance testing conducted on subject device and predicate device are listed below:

· Obturator Compatibility
· Insertion & Cannula Stability
· Air Leakage

All the test results demonstrate Unimax Trocar System meets the requirements of its pre-defined acceptance criteria and intended uses.

5.10Substantial Equivalence Determination

The Unimax Trocar System submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared ENDOPATH Bladeless Trocar, ENDOPATH Blunt Tip Trocar, ENDOPATH Dilating Tip Trocar (K032676), Shielded Surgical Trocar (K971475), and ENDOPATH Disposable Thoracic Trocar Sleeve (K920110). Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Item	ProposedDevice(UnimaxTrocar System)	Predicate Device(ENDOPATHBladeless Trocar,Blunt Tip Trocar,Dilating TipTrocar)	Predicate Device(Shielded SurgicalTrocar)	Predicate Device(ENDOPATHDisposableThoracic TrocarSleeve)
Models	Auto-locking		Shielded
	Bladeless	Bladeless
	Visible	Bladeless (Visible)
	Hasson	Blunt Tip
	Dilating	Dilating
	Secondary
	Thoracic			Thoracic

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Unimax Trocar System

ComprisedElements	Cannula	Cannula	Cannula	Cannula
	Tip of Obturator	Tip of Obturator	Tip of Obturator	Tip of Obturator
Dimension	Diameter:	Diameter:	Diameter:	Diameter:
	3-15mm	5-12mm	3-12mm	10mm
	Length:	Length:	Length:	Length:
	65-150mm	65-150mm	65-150mm	120mm
Sterilization	EO Sterilization	EO Sterilization	EO Sterilization	EO Sterilization
Safetystandards	ISO 11135-1ISO 10993-1ISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-12	ISO 11135-1ISO 10993-1ISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-12	ISO 11135-1ISO 10993-1ISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-12	ISO 11135-1ISO 10993-1ISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-12
Performancestandards	Not Applicable	Not Applicable	Not Applicable	Not Applicable
PerformanceTesting Item	ObturatorCompatibility	ObturatorCompatibility	ObturatorCompatibility	ObturatorCompatibility
	Insertion &CannulaStability	Insertion & CannulaStability	Insertion &Cannula Stability	Insertion & CannulaStability
	Air Leakage	Air Leakage	Air Leakage	Air Leakage

5.11 Conclusion

After analyzing bench tests, safety testing data, it can be concluded tha: Unimax Trocar System is as safe and effective as the predicate device.

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Unimax Medical Systems, Inc. % AcmeBiotechs Co., Ltd. Mr. Michael Lee No. 45, Minsheng Road Danshui Town, Taipei County Taiwan, China 251

FEB 1 0 2012

Re: K112358

Trade/Device Name: Unimax Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 11, 2011 Received: August 16, 2011

Dear Mr. Lee:

This is a corrected SE letter which was dated October 17, 2011.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Michael Lee

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

cerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 1123 58

Unimax Trocar System

Indications for Use

510(k) Number (if known):

Unimax Trocar System

Devicc Name:

Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, Thoracic Trocar

Indications for Use:

Prescription Use __ X (Part 21 CFR 801 Subpart D)

: :

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel RPOgden for mkn

Division of Surgical, Orthopedic, and Restorative Devices

. :

Page 1 of 1

510(k) Number K112358

ાર

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.